Galapagos' R&D Update 2017: rapidly advancing our product candidates

Galapagos NV (Euronext & NASDAQ: GLPG) announces progress made in its R&D strategy and portfolio at its Annual R&D Update on 20 June at 8 AM EDT at the Yale Club in New York City.

"I am emboldened by the execution of our strategy by the Galapagos teams that has resulted in great opportunities for our company. Galapagos now has a broad and deep pipeline with multiple product candidates across different indications. We have five proprietary clinical assets and the cash reserves to take these product candidates forward on our own into clinical development," said CEO Onno van de Stolpe.

DARWIN 3 interim readout

Patients who completed DARWIN 1 or 2 and enrolled in DARWIN 3 received filgotinib 200mg once daily or 100mg twice daily, depending on prior treatment assignment. A total of 559 patients completed week 60. Based on an observed case analysis 84%, 65%, 44%, and 51% of patients reached ACR20, ACR50, ACR70 and DAS28 (CRP) remission at Week 60 respectively. Overall exposure to filgotinib was 1314 patient-years (PYE). Safety was in line with the core studies. There were no clinically meaningful changes to male reproductive hormones measured. The totality of these safety data continues to reflect a favorable profile for filgotinib in the target population. Filgotinib is currently being investigated in three Phase 3 programs and six additional Phase 2 proof-of-concept studies: ankylosing spondylitis, psoriatic arthritis, cutaneous lupus erythematosus, Sjögren's syndrome, small bowel Crohn's, and fistulizing Crohn's. As filgotinib is currently in Phase 3 studies, the efficacy and safety of filgotinib have not yet been established.

Cystic fibrosis triple combinations

Galapagos and AbbVie have developed a large portfolio of potentiators and correctors that provides the opportunity to develop distinct triple combination therapies for CF patients. Galapagos reports that Phase 1 results on GLPG2451, GLPG2222 and GLPG2737 showed favorable findings relating to safety and tolerability of the individual components that constitute our current most advanced potential triple combination therapy. These results lead Galapagos to initiate that triple combination program, including start of the regulatory review process in Europe next month, which should allow for a patient study with '2737 in combination with Orkambi[1] and the first patient study with the triple combination '2451, '2222, and '2737 to start in Q4 2017. In addition, Galapagos anticipates starting two triple studies in 2018: one with '3067, '2222, and '2737 and one with '3067, '2222, and '3221.

Galapagos received orphan status for GLPG1690 in IPF from the US Food & Drug Administration (FDA). Galapagos has full commercial rights for '1690 and expects to announce topline results from an exploratory Phase 2a study with '1690 in IPF patients in the third quarter of 2017.

Osteoarthritis: GLPG1972 being tested in patients in the US

Galapagos is developing GLPG1972, targeting ADAMTS-5, as a potential disease-modifying therapy for osteoarthritis. Galapagos has full commercial rights in the US. Our collaboration partner Servier will be making its opt-in decision for further development and ex-US commercial rights later this year. Galapagos opened an Investigational New Drug (IND) dossier with the FDA for '1972 and achieved first dosing in a Phase 1b patient trial in the US. This exploratory dose escalation study will investigate the safety and tolerability, pharmacokinetics and pharmacodynamics of '1972 in 30 patients with hip and/or knee osteoarthritis after 4 weeks of oral administration. Completion of patient recruitment is expected by the end of 2017.

Additional pipeline progress

Galapagos expects to report topline results with MOR106, a human monoclonal antibody targeting IL-17C, in a Phase 1b trial in atopic dermatitis patients later in 2017. Furthermore, Galapagos expects to initiate a new study with GPR84 inhibitor GLPG1205 in an undisclosed indication later in 2017. Galapagos nominated GLPG2384 in an undisclosed indication and GLPG3121 in psoriasis, increasing the number of fully proprietary clinical stage assets to five.

Webcast presentation and conference call

Galapagos will webcast the R&D Update tomorrow (20 June 2017) at 8.00 Eastern Time (ET) and 14:00 Central European Time (CET), together with a conference call. To participate in the latter, please call one of the following numbers ten minutes prior to commencement:

A question and answer session will follow the presentation of the R&D Update. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.

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